SuspendedNot Applicable

Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

Stopped: Suspended due to low patient enrollment resulting from low commercial usage of Adasuve. Study continuation is impractical. Alexza has been in discussions with FDA on this matter.

United States10,000 participantsStarted 2014-11-04

Plain-language summary

This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The patient is a man or woman who is 18 years of age or older at time of enrollment.
✓. The patient is receiving ADASUVE for agitation in a medical or psychiatric emergency setting or in a psychiatric inpatient setting. (Note: Patients with a prior history of treatment with ADASUVE may also be included in the study.)
✓. The patient (or caregiver or legally authorized representative) is willing and able to provide written informed consent (and assent, where applicable) after administration of ADASUVE treatment.

What they're measuring

Evaluating frequency and nature of adverse events, serious adverse events and respiratory adverse events of special interest (AESIs) after administration of ADASUVE treatment in real-world clinical settings

Timeframe: 24 hours

Trial details

NCT IDNCT03513549

SponsorAlexza Pharmaceuticals, Inc.

Sponsor typeUNKNOWN

Study typeOBSERVATIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Agitation,Psychomotor trials